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The status of clinical trials has been under the spotlight recently.


3 4 Stiller reviewed published data on survival rates for cancer in relation to patterns of organisation of medical care–specifically treatment by protocol, usually within the context of a clinical trial, and also treatment at specialist centres.1 Entry into trials (and centralised referral) was often associated with higher survival rates, particularly with less common cancers, and was never found to be associated with a lower survival rate.

Patients themselves are usually willing to participate, attracted by being treated by a doctor with a specialist interest and encouraged by the promise of close monitoring of their progress.2 In our series only four refused to enter when asked.

Many patients are considered for studies but not entered on the clinician's decision. Even with our own group's positive attitude to trials and policy of putting as many patients as possible into studies, this explanation has consistently accounted for around 7% of patients. Almost half of our patients, however, were not considered for trials for genuine reasons: the eligibility criteria of particular trials excluded them on age or medical grounds or there was no appropriate current trial (old trials finished, new trials not yet started–as was the case in the last two years of our study period, when recruitment was temporarily lower). Such selection may be an important factor in determining the different outcomes between patients who take part in trials and those who do not. In particular, older and iller patients tend not to be entered into studies, and survival in this group will naturally be poor.

http://www.bmj.com/cgi/content/short/314/7073/36